(18 days)
Not Found
Not Found
No
The summary describes a physical medical device (guiding catheter) and its construction, with no mention of software, algorithms, or AI/ML terms.
No
The device is described as a "guiding catheter" which provides a pathway for other "therapeutic devices" to be introduced. It is not itself a therapeutic device.
No
The device is described as a guiding catheter designed to provide a pathway for introducing other therapeutic devices. Its function is to facilitate the delivery of treatment, not to diagnose a condition.
No
The device description clearly describes a physical catheter with specific dimensions, materials, and construction, indicating it is a hardware device, not software only.
Based on the provided information, the Medtronic® Zuma™ Guiding Catheter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "provide a pathway through which therapeutic devices are introduced" within the "coronary or peripheral vascular system." This describes a device used in vivo (within the body) for a procedural purpose, not for testing samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description focuses on the physical construction and dimensions of a catheter designed for insertion into blood vessels. This aligns with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other elements typically associated with in vitro diagnostic testing.
Therefore, the Medtronic® Zuma™ Guiding Catheter is a medical device used for interventional procedures within the vascular system, not an IVD.
N/A
Intended Use / Indications for Use
The Medtronic® Zuma™ Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The Zuma™ catheter is intended to be used in the coronary or peripheral vascular system.
Product codes
DQY
Device Description
The Medtronic® Zuma™ Guiding Catheters will be available in 5F - 9F outer diameters. The 6F and 9F (non-segmented) catheter is constructed with a braided proximal shaft with an inner liner and a soft distal tip. The 5F, 7F, 8F and 9F(segmented) Zuma catheters are manufactured with a braided proximal shaft and segments, an inner liner and a soft distal tip. The inner lumen of the Zuma™ catheter has a thin lubricious coating. The Zuma™ Guiding Catheter (6F - 9F) has a larger inner lumen diameter than its predicate devices. The 5F Zuma is comparable in stiffness to a 6F predicate device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary or peripheral vascular system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Test results verified that the Medtronic® Zuma™ Ouiding Catheters meet all of the applicable specifications and are deemed adequate for the intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Medtronic® 6F Zuma™ Guiding Catheter, Medtronic® 7F. 8F Zuma™ Guiding Catheter, Medtronic® Vector™ X Guiding Catheter, Cordis® Brite Tip® Guiding Catheter
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
3/22/99
510(k) Notification Medtronio® Zuma™ Guiding Catheter
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Pursuant to Section 12, Safe Medical Devices Act of 1990)
- The trade or proprietary name of the device is the Medtronic® Zuma™ Guiding Catheter. The l . Medtronic® Zuma™ Guiding Catheter will be available in 5F- 9F sizes and in curve styles similar to the current Medtronic Guiding Catheters.
- The Medtronic® Zuma™ Guiding Catheter is designed to provide a pathway through which 2. therapeutic devices are introduced. The guiding catheter is intended to be used in the coronary or peripheral vascular system.
- The Medtronic® Zuma™ Guiding Catheters will be available in 5F 9F outer diameters. The 6F and 3. 9F (non-segmented) catheter is constructed with a braided proximal shaft with an inner liner and a soft distal tip. The 5F, 7F, 8F and 9F(segmented) Zuma catheters are manufactured with a braided proximal shaft and segments, an inner liner and a soft distal tip. The inner lumen of the Zuma™ catheter has a thin lubricious coating. The Zuma™ Guiding Catheter (6F - 9F) has a larger inner lumen diameter than its predicate devices. The 5F Zuma is comparable in stiffness to a 6F predicate device.
- All appropriate Biocompatibility tests were successfully performed on the materials used for the 4. Medtronic® Zuma™ Guiding Catheter.
- న్. Test results verified that the Medtronic® Zuma™ Ouiding Catheters meet all of the applicable specifications and are deemed adequate for the intended use. The Zuma™ guide catheter is considered to be substantially equivalent to the following device:
- Medtronic® 6F Zuma™ Guiding Catheter ●
- . Medtronic® 7F. 8F Zuma™ Guiding Catheter
- Medtronic® Vector™ X Guiding Catheter ●
- Cordis® Brite Tip® Guiding Catheter .
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird with three human profiles incorporated into its design, suggesting a connection between health, humanity, and government services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 2 1999
Mr. Mark Chartier Quality Assurance and Regulatory Affairs Director Medtronic Interventional Vascular, Inc. 37A Cherry Hill Drive Danvers, MA 01923
Re: K990707 Medtronic® Zuma™ Guiding Catheter Trade Name: Requlatory Class: II Product Code: DQY Dated: March 3, 1999 Received: March 4, 1999
Dear Mr. Chartier:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerninq your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation
2
Page 2 - Mr. Mark Chartier
you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) Additionally, for questions on the promotion and advertising 594-4586. of your device, please contact the Office of Compliance at (301) 594- Also, please note the regulation entitled, "Misbranding by 4639. reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callehan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE
510(k) Number: To be assigned by FDA K996707
Device Name:
Medtronic® Zuma™ Guiding Catheter
Indications for Use:
The Medtronic® Zuma™ Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The Zuma™ catheter is intended to be used in the coronary or peripheral vascular system.
u'
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
Victor Lam Hu
rdiovascular, Respiratory, 510(k) N